3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis
Authors: John K. Forrest, G. Michael Deeb, Steven J. Yakubov, Hemal Gada, Mubashir A. Mumtaz, Basel Ramlawi, Tanvir Bajwa, Paul S. Teirstein, Michael DeFrain, Murali Muppala, Bruce J. Rutkin, Atul Chawla, Bart Jenson, Stanley J. Chetcuti, Robert C. Stoler, Marie-France Poulin, Kamal Khabbaz, Melissa Levack, Kashish Goel, Didier Tchétché, Ka Yan Lam, Pim A.L. Tonino, Saki Ito, Jae K. Oh, Jian Huang, Jeffrey J. Popma, Neal Kleiman, Michael J. Reardon, Paul Sorajja, Timothy Byrne, Merick Kirshner, Tanvir Bajwa, John Crouch, Joseph Coselli, Guilherme Silva, Robert Hebeler, Robert Stoler, Ashequl Islam, Anthony Rousou, Marie-France Poulin, Kamal Khabbaz, Mark Bladergroen, Peter Fail, Donald Netherland, Ka Yan Lam, W.A.L. Tonino, Arnaud Sudre, Pierre Berthoumieu, Didier Tchétché, Houman Khalili, G. Chad Hughes, J Kevin Harrison, Ajanta De, Pei Tsau, Nicolas M. van Mieghem, Robert Larbalestier, Gerald Yong, Shikhar Agarwal, William Martin, Steven Park, Neal Kleiman, Michael Reardon, Siamak Mohammadi, Josep Rodes-Cabau, Jeffrey Sparling, C. Craig Elkins, Brian Ganzel, Ray V. Matthews, Vaughn A. Starnes, Kenji Ando, Bernard Chevalier, Arnaud Farge, Michael DeFrain, Murali Muppala, William Combs, Rodrigo Bagur, Michael Chu, Gregory Fontana, Visha Dev, Ferdinand Leya, J. Michael Tuchek, Ignacio Inglessis, Arminder Jassar, Nicolo Piazza, Kevin Lacappelle, Daniel Steinberg, Marc Katz, John Wang, Joseph Kozina, Frank Slachman, Robert Merritt, Atul Chawla, Bart Jensen, Jorge Alvarez, Robert Gooley, Julian Smith, Reda Ibrahim, Raymond Cartier, Joshua Rovin, Tomoyuki Fujita, Bruce Rutkin, Steven Yakubov, Howard Song, Firas Zahr, Shigeru Miyagawa, Vivek Rajagopal, James Kauten, Hemal Gada, Mubashir Mumtaz, Ravinay Bhindi, Peter Brady, Sanjay Batra, Thomas Davis, Ayman Iskander, David Heimansohn, James Hermiller, Itaru Takamisawa, Thomas Haldis, Seiji Yamazaki, Paul Teirstein, Norio Tada, Shigeru Saito, William Merhi, Stephane Leung, David Muller, Robin Heijmen, George Petrossian, Newell Robinson, Peter Knight, Frederick Ling, Sam Radhakrishnan, Stephen Fremes, Eric Lehr, Sameer Gafoor, Thomas Noel, Antony Walton, Jon Resar, David Adams, Samin Sharma, Scott Lilly, Peter Tadros, George Zorn, Harold Dauerman, Frank Ittleman, Erik Horlick, Chris Feindel, Frederick Welt, Vikas Sharma, Alan Markowitz, John Carroll, David Fullerton, Bartley Griffith, Anuj Gupta, Eduardo de Marchena, Tomas Salerno, Stanley Chetcuti, G. Michael Deeb, Ibrahim Sultan, Kashish Goel, Sanjeevan Pasupati, Neal Kon, David Zhao, Basel Ramlawi, John Forrest
Journal: Journal of the American College of Cardiology (2023)

Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low–surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process. The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial. Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years. There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: −1.8% at year 1; −2.0% at year 2; and −2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years. Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283)